|
Class 2 Device Recall American Catheter 9100 Series |
|
Date Initiated by Firm |
March 17, 2015 |
Date Posted |
July 22, 2015 |
Recall Status1 |
Terminated 3 on December 14, 2016 |
Recall Number |
Z-2191-2015 |
Recall Event ID |
71263 |
Product Classification |
Catheter, cholangiography - Product Code GBZ
|
Product |
American Catheter / Cholangiogram Catheter 9100 Series.
|
Code Information |
Product Number is 9100, Lot # 14101601. |
Recalling Firm/ Manufacturer |
American Catheter Corp 13047 S Highway 475 Ocala FL 34480-8503
|
For Additional Information Contact |
Todd Cantine 800-345-6714
|
Manufacturer Reason for Recall |
Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
|
FDA Determined Cause 2 |
Process control |
Action |
Consignees were contacted by telephone of the affected lot number and sent a Recall Script dated 3/17/2015 giving instructions how to respond to this recall. |
Quantity in Commerce |
890 devices. |
Distribution |
Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|